Beneficiary Advisory Panel Handout Uniform Formulary Decisions 6 Jan 2011
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1 Beneficiary Advisory Panel Handout Uniform Formulary Decisions 6 Jan 2011 PURPOSE: The purpose of this handout is to provide BAP Committee members with a reference document for the relative clinical effectiveness presentations for each Uniform Formulary (UF) Class review 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 1 of 17
2 Table 1: Uniform Formulary Recommendations from the v 2010 DoD P&T Committee meeting for the n-insulin Anti-Diabetic Drugs n-insulin Anti-Diabetic Drugs Subclass UF recommendation Generic Drug Name (Brand) DPP-4 GLP-1 TZDs Biguanides Sulfonylureas AGI UF Class step applies See note 1 UF Class and subclass step apply see note 1,2 UF Class step applies See note 1 NF Class step applies See note 1 Step Preferred UF NF Step Preferred UF UF Sitagliptin (Januvia) Sitagliptin+met (Janumet) Saxagliptin (Onglyza) Exenatide (Byetta) Liraglutide (Victoza) Pioglitazone (Actos) Pioglitazone+met (Actoplus Met) Pioglitazone+met ER (Actoplus Met XR) Pioglitazone/glimepiride (Duetact) Rosiglitazone (Actos) Rosiglitazone/metformin (Avandamet) Rosiglitazone/glimepiride (Avandaryl) Metformin IR 500, 850, 1000 mg Riomet liq 500/5 Metformin ER 500, 750 mg Metformin ER (Fortamet ER) 500, 1000 mg Metformin ER (Glumetza) 500, 1000 mg Chlorpropamide Tolazamide Tolbutamide Glimepiride Glipizide Glipizide ER Glyburide Glyburide micronized Glipizide/met Glyburide/met Acarbose (Precose) Miglitol (Glyset) Generic Available Amylin Agonists UF Pramlintide (Symlin) Meglitinides UF Nateglinide Repaglinide +/- met (Prandin,Prandimet) tes: 1. Patient must have a documented trial or contraindication for metformin or a sulfonylurea prior to receiving a drug in this subclass. 2. Patient must have a documented trial or contraindication for Byetta prior to receiving Victoza Recommended implementation period 60 days 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 2 of 17
3 Figures 1: Anti-diabetic Subclass Utilization - 30 Day Equivalents at All POS Figure 2: Biguanide (Metformin) 30 Day Equivalents at All POS 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 3 of 17
4 Figure 3: Sulfonylureas 30 day Equivalents at All POS Figure 4: DPP-4 Utilization 30 Day Equivalents at All POS 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 4 of 17
5 Figure 5: GLP-1 Utilization -30 Day Equivalents at All POS Figure 6: TZD Utilization 30 Day Equivalents at All POS 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 5 of 17
6 Figure 7: Meglitinide 30 day Equivalents at All POS Figure 8: AGI 30 Day Equivalents at All POS 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 6 of 17
7 Figure 9: Amylin Agonists 30 day Equivalents at All POS 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 7 of 17
8 Table 2: Inhaled Corticosteroid/Long-Acting Beta Agonists Drug Class Generic Name (Brand) Formulations ICS/LABA combinations Generics Available? Uniform Formulary n-formulary Fluticasone/salmeterol (Advair ) Diskus DPI/HFA MDI Budesonide/Formoterol (Symbicort ) pmdi Mometasone/Formoterol (Dulera) HFA MDI ne Dulera was recommended for UF placement with Quantity Limits Recommended implementation period pmdi: pressurized metered dose inhaler DPI: dry powder inhaler HFA: hydrofluoroalkane 60 days Figure 10: Inhaled Corticosteroid/Long-Acting Beta Agonists Dulera (mometasone/formoterol inhaler) Grams dispensed 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 8 of 17
9 Table 3: Antilipidemic-1s Drug Class Generic Name (Brand) Formulations Antilipidemic 1s - Statins, Statin Combinations, Ezetimibe, & Niacin Generics Available? Statins Atorvastatin (Lipitor) tabs Fluvastatin (Lescol) tabs Fluvastatin ER (Lescol XL) tabs Lovastatin IR (Mevacor) tabs Lovastatin ER (Altoprev) tabs Pravastatin (Pravachol) tabs Simvastatin (Zocor) tabs Uniform Formulary Rosuvastatin (Crestor) tabs Statin Combinations Atorvastatin / amlodipine (Caduet) tabs Lovastatin / niacin ER (Advicor) tabs Simvastatin / niacin ER (Simcor) tabs Simvastatin/ ezetimibe (Vytorin) tabs Add-on therapies Ezetimibe (Zetia) tabs Niacin ER (Niaspan) tabs Niacin IR (Niacor) tabs n-formulary Pitavastatin (Livalo) tabs Pitavastatin was recommended to be made non-formulary Recommended implementation period 60 days Figure 11: Antilipidemic-1s Livalo (pitavastatin tablets) 30 day equivalents 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 9 of 17
10 Table 4: Newer Sedative Hypnotic Newer Sedative-Hypnotic Agents UF Status Generic Name (Brand) Formulations Generics Available? Zolpidem Immediate Release (Ambien) tab yes Uniform Formulary Eszopiclone (Lunesta) tab no Doxepin (Silenor) tab no Ramelteon (Rozerem) tab no n-formulary Zaleplon (Sonata) cap yes Zolpidem ER (Ambien CR) tab no Zolpidem (Edluar) sublingual no Silenor recommended to be Uniform Formulary Recommended implementation period 60 days for prior authorization on Silenor Figure 12: Newer Sedative Hypnotic Silenor (doxepin tablets) Qty dispensed 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 10 of 17
11 Table 5: Narcotic Analgesic Exalgo (hydromorphone extended release tablets) Uniform Formulary Recommendations from v 2010 for the Narcotic Analgesics Narcotic Analgesics UF Status Generic Name (Brand) Formulations Generics Available? High-potency single analgesic agents Long-acting agents (> 12 hour duration) Fentanyl transdermal system (Duragesic) patch Morphine sulfate ER 24 hr (Kadian, Avinza) cap Hydromorphone ER 24 hr (Exalgo ) ER tabs Morphine sulfate ER 12 hr (MS Contin, Oramorph) tab, soln, supp, inj Morphine sulfate ER/Naltrexone (Embeda) caps Oxycodone ER (Oxycontin) tabs Oxymorphone (Opana ER) tabs Short acting agents (<12 hour duration) Codeine tabs, soln, inj Fentanyl citrate buccal (Fentora) tabs Fentanyl citrate transmucosal (Actiq) lozenges Uniform Formulary Fentanyl citrate transmucosal soluble film (Onsolis) Soluble Film, except for Hydromorphone (Dilaudid) tab, inj, liquid 1 mg tab Levorphanol (Levo-Dromoran) tab, inj Meperidine (Demerol) tab, soln, inj Meperidine / promethazine (Mepergan Fortis) caps Methadone (Dolophine) tab, oral conc, soln, inj Morphine sulfate IR tabs Opium tincture Opium / belladonna alkaloids supp Oxycodone IR caps, oral conc, soln Oxymorphone IR (Opana) tabs High-potency combination agents Oxycodone /APAP (e.g., Percocet, Tylox, others) tab, cap, soln Oxycodone / ASA (Percodan) tabs Low potency single analgesic agents Buprenorphine (Buprenex) inj (excludes SL tabs) Butorphanol (Stadol) nasal spray, inj Pentazocine / naloxone (Talwin NX) tabs Propoxyphene (Darvon) caps, tabs Nalbuphine (Nubain ) not a controlled substance) Inj Tramadol IR(Ultram) not a controlled substance tab 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 11 of 17
12 Table 5: Narcotic Analgesic Exalgo (hydromorphone extended release tablets) Uniform Formulary Recommendations from v 2010 for the Narcotic Analgesics (continued) Uniform Formulary Low potency combination agents Codeine / APAP (Tylenol with codeine) tabs, elixir, oral susp Codeine / ASA tabs Codeine / ASA / carisoprodol (Soma) tabs Codeine / caffeine / butalbital / APAP (Fioricet with codeine) caps Codeine / caffeine / butalbital / ASA (Fiorinal with caffeine) caps, tabs Dihydrocodeine / caffeine / APAP e.g., Panlor DC, Panlor SS) caps, tabs Dihydrocodeine / caffeine / ASA (Synalgos-DC) caps Hydrocodone / APAP (e.g., Lortab, Lorcet, Vicodin, others) caps Pentazocine / APAP (Talacen) tabs Propoxyphene / APAP (Darvocet) tabs n-formulary Propoxyphene / ASA / caffeine (Darvon Compound 65) Tramadol/APAP (Ultracet) not a controlled substance Low potency single analgesic agents caps Tramadol ER (Ultram ER and Ryzolt) tab High potentcy single analgesic agents; short-acting agents (<12 hours duration) tab Tapentadol (Nucynta) tab Exalgo revommended to be Uniform Formulary Recommended Implementation Period t Applicable for Exalgo Figure 13: Narcotic Analgesic Exalgo (hydromorphone ER tablets) Total Qty Dispensed 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 12 of 17
13 Table 6: Antilipidemic-2s Antilipidemic II (LIP-2s) UF Status / Implementation Period Formulary n-formulary Generic Name (Brand) Formulations Generics Available? Fibric Acid Derivatives Fenofibrate meltdose (Fenoglide ) Tab Fenofibrate IDD-P (micronized) (Triglide) tab Fenofibrate micronized/nonmicronized (Lofibra) tab/cap Gemfibrozil (Lopid) tab Bile Acid Sequestrants (BAS) Cholestyramine (Questran, Questran Light) powder Colestipol (Colestid) tab Fibric Acid Derivatives Fenofibrate acid (Fibricor) caps Fenofibrate acid (Trilipix) caps Fenofibrate nanocrystallized (Tricor) tab Fenofibrate micronized (Antara) cap Omega-3 fatty acids Prescription omega-3 fatty acids (Omacor) cap Bile Acid Sequestrants (BAS) Colesevelam (Welchol) tab Fenofibrate acid (Fibricor) recommended to be Uniform Formulary Recommended implementation period 60 days for Fibricor Figure 14: Antilipidemic-2s Fibricor (fenofibric acid) 30 day Equivalents 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 13 of 17
14 Table 7: Contraceptives Contraceptives Uniform Formulary EE 20 mcg; 0.1 mg levonorgestrel EE 20 mcg; 1.0 mg norethindrone Monophasic OCs with 20 mcg EE EE 20 mcg; 1.0 mg norethindrone; ferrous fumarate EE 20 mcg; 3 mg drospirenone (Yaz) EE 30 mcg; 0.15 mg levonorgestrel (excluding Seasonale) EE 30 mcg; 0.3 mg norgestrel EE 30 mcg; 0.15 mg desogestrel Monophasic OCs with 30 mcg EE EE 30 mcg; 1.5 mg norethindrone EE 30 mcg; 1.5 mg norethindrone; ferrous fumarate EE 30 mcg; 3 mg drospirenone (Yasmin) EE 35 mcg; 0.5 mg norethindrone EE 35 mcg; 0.25 mg norgestimate Monophasic OCs with 35 mcg EE EE 35 mcg; 1.0 mg norethindrone EE 35 mcg; 1.0 mg ethynodiol diacetate Mestranol 50 mcg; 1 mg norethindrone Monophasic OCs with 50 mcg EE or EE 50 mcg; 1 mg ethynodiol diacetate mestranol EE 50 mcg; 0.5 mg norgestrel EE 35 mcg; 0.5/1.0 mg norethindrone Biphasic OCs EE 20/10 mcg; 0.15 mg desogestrel EE 25 mcg; 0.18/0.215/0.25 mg norgestimate (Ortho Tri-Cyclen Lo) EE 35 mcg; 0.18/0.215/0.25 mg norgestimate EE 30/40/30 mcg; 0.05/0.075/0.125 mg levonorgestrel Triphasic OCs EE 35 mcg; 0.5/1/0.5 mg norethindrone EE 35 mcg; 0.5/0.75/1 mg norethindrone EE 25 mcg; 0.1/0.125/0.15 mg desogestrel Progestogen-only OCs 0.35 mg norethindrone Patch EE; norelgestromin (Ortho-Evra) Vaginal ring EE; etonorgestrel (Nuvaring) 104 mg/ 0.65mL depot medroxyprogesterone acetate Injectable (Depo-subq Provera 104) 150 mg/ml depot medroxyprogesterone acetate Emergency contraceptives 0.75 mg levonorgestrel (Plan B) Estradiol valerate/dienogest (Natazia) n- Formulary EE 30 mcg; levonorgestrel 0.15 mg in special packaging for extended use (Seasonale) EE 35 mcg; 0.4 mg norethindrone (Ovcon 35) EE 50 mcg; 1 mg norethindrone (Ovcon 50) EE 20/30/35 mcg; norethindrone 1 mg (Estrostep Fe) Implementation 60 days Plan EE = ethinyl estradiol; OC = oral contraceptive. Natazia recommended for non formulary 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 14 of 17
15 Figure 15: Contraceptive Agents Natazia (estradiol valerate/dienogest) 30 day Equivalents 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 15 of 17
16 Table 7 Table of Implementation Status of UF Recommendations/Decisions Summary Table Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy v 2010 n-insulin Diabetes Drugs Biguanides Metformin ER 500, 1000 mg (Fortamet) Metformin ER 500, 1000 mg (Glumetza) 4, days no v 2010 n-insulin Diabetes Drugs Thiazolidinediones Rosiglitazone (Avandia) Rosiglitazone/ metformin (Avandamet) Rosiglitazone/ glimepiride (Avandaryl) 6698 (new users who will hit metformin/sulf step per quarter) 17,497 Rosi and combo patients 60 days Automated PA applies with metformin or a sulfonylurea preferred v 2010 n-insulin Diabetes Drugs DPP-4 Inhibitors ne 7844 (new users who will hit metformin/sulf step per quarter) 60 days Automated PA applies with metformin or a sulfonylurea preferred v 2010 n-insulin Diabetes Drugs GLP-1 Receptor Agonists ne 2229 (new users who will hit metformin/sulf step per quarter) of those 1962 Victoza users will hit Byetta preferred step 60 days Automated PA applies with metformin or a sulfonylurea preferred Automated PA applies with Byetta preferred v 2010 Antilipidemic Agents I Pitavastatin (Livalo) (v 2010) days Automated PA with generics or atorvastatin or atorvastatin as the preferred drugs v 2010 Antilipidemic Agents II Fenofibric acid (Fibricor) (v 2010) days ne 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 16 of 17
17 Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy v 2010 Contraceptive Agents Estradiol valerate/dienogest (Natazia) (v 2010) See TRICARE formulary search tool* for remainder of NF drugs days ne v 2010 Newer Insomnia ne 230 (new users hit step in the first month of use) 60 days Automated PA applies with zolpidem IR preferred 6 Jan 2011 Beneficiary Advisory Panel Meeting Page 17 of 17
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